An interventional study of Essential amino acid supplement and Placebo in Older Adults Without Any Specific Clinical Condition, sponsored by Leeds Beckett University. Completed at 1 site in United Kingdom. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Leeds Beckett University · Not applicable, Interventional, and Supportive care
Healthy older adults and those who have acute and chronic conditions suffer from reduced protein intake and are at risk of developing both chronic and acute sarcopenia. Amino acid supplementation can provide appropriate conditions for muscle protein synthesis to occur. However, the exact amino acid ratio that may optimise this is currently unknown. The purpose of this crossover trial is to compare different amino acid gels and identify which results in the greatest concentration of plasma amino acids following a standardised breakfast. This will allow development of management strategies for healthy and diseased populations who suffer from reduced protein intake.
Sarcopenia refers to a skeletal muscle disorder via loss of muscle strength, mass and function that naturally progresses with age. More recently however, the phenomenon of acute sarcopenia (AS) has been suggested which refers to sarcopenia that occurs within a period of six months. This rapid deterioration of muscle, which typically occurs as a result of an illness or stressor, significantly increases the risk of hospital admission, loss of independence, and mortality making it an important target for future research.
Poor nutrition and specifically inadequate energy and dietary protein intakes are contributors to the development of both sarcopenia and AS. Therefore, addressing energy and protein deficiencies have been proposed in review papers as a means to prevent and/or better manage sarcopenia and AS. This is not something that has been explicitly investigated within this specific clinical population to date. Nutritional interventions which are focused on addressing total energy and protein deficiencies will optimise skeletal muscle adaptations via essential amino acids, particularly Leucine, found in protein acting as an important anabolic stimulus for the mammalian target of rapamycin (mTOR). Therefore, this type of management strategy should be able to attenuate the muscle wasting and exacerbated life outcomes (mortality, loss of independence, frailty) that occurs in AS and among other serious health conditions.
Older populations require approximately 30-40g of protein per meal ( ̴0.45 g/kg/BM/Day), with particular importance of leucine, in order to achieve recent recommended daily amounts of 1.2-1.6g/kg/BM/day but this is difficult to achieve in the older population which naturally suffers from a reduced appetite and increased perception of fullness. Breakfast and lunch commonly suffer from the greatest deficiency in protein intake and Ispoglou et al. have developed effective ways in which to increase dietary protein intake without affecting hunger.
The gels which Ispoglou et al. have developed contain 7.5g of essential amino acids (EAAs) per sachet of 65 ml volume each, the equivalent found in 15g of high-quality protein (3g of leucine), and the addition of one of these gels alongside a meal could potentially assist older adults to reach optimal protein requirements on a per meal and daily basis. Previously, supplementation with EAAs has shown to be effective in increasing functional performance and lean tissue mass, while it has been proposed as a potential nutritional therapy for addressing sarcopenia. These EAA gels also do not affect appetite in older adults and have been shown to be an effective means for enhancing both protein and energy intake in older adults.
Supplementation with such gels, as we have shown, can increase plasma concentrations of essential amino acids (AAs), such as leucine, which in turn can act as anabolic stimuli and enhance muscle protein synthesis and potentially prevent or minimise muscle wasting. Plasma concentrations of amino acids, in particular leucine, drives muscle protein synthesis however an excessive concentration of leucine can increase oxidation rates of other essential amino acids, in particular L-isoleucine and L-valine, meaning there is lower plasma availability for muscle protein synthesis. Thus, it is important to identify which AA ratio can maximise the potential for muscle protein synthesis rather than increase oxidation of AAs and limit muscle protein synthesis.
This study will evaluate the plasma concentration of AAs following ingestion of gels with different AA ratios following a standardised breakfast meal. Gel A is based on a formulation devised by Ispoglou et al. and Gel B based on a formulation devised by Kobayashi et al. Therefore, the primary outcome measure is the plasma concentration of essential AAs.
The hypothesis is that the AA supplements will increase plasma AA concentrations versus the placebo, and the different AA ratios may result in different concentrations of plasma AAs.
The main research question for this study will be:
- Which of the gel formulas (Gel A, Gel B, or placebo) will provide the greatest plasma concentrations of AAs?
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 855 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Leeds Beckett University is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An essential amino acid supplement based on Ispoglou et al. (2016; 2017)'s previous work.
Dietary Supplement: Essential amino acid supplement
An essential amino acid supplement based on Kobayashi et al. (2010)'s previous work.
Dietary Supplement: Essential amino acid supplement
An energy matched placebo containing no amino acids.
Dietary Supplement: Placebo
Two active comparators containing a unique composition of essential amino acids reported previously by Ispoglou et al. (2016; 2017) and Kobayashi et al. (2010).
An energy-matched plaecbo supplement containing no amino acids.
Plasma amino acid concentration
A series of blood samples collected prior to and post-supplementation were assessed using liquid chromatography tandem mass spectrometry (LC-MS/MS) methods to accurately quantify the plasma concentrations of 15 amino acids. This allowed individual amino acid analysis as well as grouped analysis of non-essential, essential, and branched-chain amino acids.
Time frame: Baseline (pre-supplementation), 15 minutes post-supplementation, and then every 30 minutes for the following 3 hours.
Appetite
Using visual analogue scales, feelings of hunger and appetite were recorded throughout the observation period in line with the timings of the blood samples. The scales assessed feelings of hunger, appetite, satiety, and fullness and a desire for sweet, salty, fatty or savoury. This was assessed on a 100mm line where the participant would mark their feelings. A score closer to 100mm indicated a stronger sensation of the metric in question.
Time frame: Baseline (pre-supplementation), 15 minutes post-supplementation, and every 30 minutes thereafter for the following 3-hours.
Palatability
Palatability of each supplement was assessed using visual analogue scales. The scale considered visual appeal, smell, taste, aftertaste, and overall palatability. This was assessed on a 100mm line where the participant would mark their feelings. A score closer to 100mm indicated a stronger sensation of the metric in question.
Time frame: Immediately post-supplementation
Plan to share: No — Participant data will be grouped before analysis and reported in an anonymised manner.
Ran from Jun 2022 to primary completion in Dec 2022, 5 months.
Of 492 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's 5 months is below that.
Counting every sponsor, half of 503 studies reached it within 18 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Leeds Beckett University